BECTON DICKINSON MEDICAL SYSTEMS

FDA MAUDE device safety record · 2003–2026

What the Data Shows About BECTON DICKINSON MEDICAL SYSTEMS

BECTON DICKINSON MEDICAL SYSTEMS is associated with 9,569 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2003 through 2026. Of the total, 22 are coded as death reports and 360 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 19 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for BECTON DICKINSON MEDICAL SYSTEMS should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 9,184 reports (96.0% of total). Patient-outcome categorizations are reported across 10 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 18 years of MAUDE data, with the peak single-year volume reaching 1,527 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

9,569
Total Reports
22
Death Reports
360
Injury Reports
19
Device Types

Event Types

Malfunction 9,184 (96.0%)
Injury 360 (3.8%)
Death 22 (0.2%)
Other 2 (0.0%)
1 (0.0%)

Patient Outcomes

5,728 (59.7%)
Other 3,567 (37.2%)
Required Intervention 199 (2.1%)
R 34 (0.4%)
Hospitalization 29 (0.3%)
Death 24 (0.3%)
O 6 (0.1%)
Disability 4 (0.0%)
H 2 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

03
2003: 2
04
2004: 5
05
2005: 3
06
2006: 1
08
2008: 1
13
2013: 3
15
2015: 15
16
2016: 49
17
2017: 406
18
2018: 1,078
19
2019: 1,315
20
2020: 959
21
2021: 834
22
2022: 1,369
23
2023: 1,527
24
2024: 1,046
25
2025: 846
26
2026: 110

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.